MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367294
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a replacement to the original submission under mfr report # 1024879-2025-00366 on (b)(6) 2025 in order to file against the correct site registration number.The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.Investigation summary: bd had not received samples or photos for investigation.Therefore, (b)(4) retained samples of the lot concerned were visually checked and no abnormal appearance of the tubing, connectors or other parts that could inhibit the blood from flowing into the device were found.Also, a light was run through the butterfly needles and luer adaptors of 8 retained samples, and no clogging was found as the light was able to be observed through the needles and luer adaptors.Additionally, (b)(4) retained samples of the lot were evaluated by functional testing for flow and leakage test, and the issue of insufficient blood flow was not seen as all the samples met within specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of insufficient blood flow based on retains testing.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using 295 bd vacutainer® safety-lok¿ blood collection set, the customer noticed the blood flow was very slow, causing the samples to coagulate or not to reach an optimal capacity.There was no health impact or consequence reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22055733
• Report Number: 2243072-2025-00661
• Device Sequence Number: 4109748
• Product Code: JKA
• UDI-Device Identifier: 30382903672944
• UDI-Public: (01)30382903672944(11)230502(17)260131(10)23A31A1
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 367294
• Device Lot Number: 23A31A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown